Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Study information

Scientific title

Age of BLood Evaluation (ABLE) trial in the resuscitation of critically ill patients: a multicentre randomised controlled superiority clinical trial

Acronym

ABLE

Study hypothesis

The transfusion of fresh leuko-reduced red cells (stored for less than 8 days) will lead to a 5% or greater improvement in 90 day all cause mortality and clinically important decreases in morbidity in a vulnerable population of critically ill patients.

Condition

Intervention

Experimental: Transfusions of red cells stored less than 8 days issued by the local blood bank. This will be applied up to discharge from the hospital or step-down unit (not more than 90 days post-randomisation).

Intervention type

Other

Phase

Drug names

Primary outcome measures

90-day all cause mortality

Secondary outcome measures

1. Other mortality rates and survival times as measured at ICU discharge, hospital discharge, 28 days and 6 months post-discharge2. Number of cases of multiple organ dysfunction syndrome (MODS), highest number of organ failures per patient, MODS score and time to development of MODS as measured while in the ICU3. Serious nosocomial infections including:3.1. Nosocomial pneumonia3.2. Deep tissue infections (e.g. peritonitis, mediastinitis)3.3. Bacteraemia from organisms not considered normal skin flora and judged important enough to treat by the attending team, as measured while in the ICU4. Adverse events and transfusion reactions as measured while in ICU5. Length of stay (ICU and hospital)6. Length of time requiring respiratory, haemodynamic and renal support as measured while in ICU

Overall trial start date

01/12/2008

Overall trial end date

01/04/2013

Reason abandoned

Eligibility

Participant inclusion criteria

Patients who:1. Have had a request for a first red cell unit transfusion in the Intensive Care Unit (ICU), and2. Have an anticipated length of invasive and/or non-invasive continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BIPAP) mechanical ventilation of at least 48 hours once enrolled, as estimated by the attending physician

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

2510

Participant exclusion criteria

Investigators and research assistants will exclude patients:1. Who are less than 16 years of age2. Who were previously enrolled in the ABLE study3. Who have already been transfused with red cells during the current hospitalisation4. Who have an obvious terminal illness documented in the medical record with a life expectancy of less than 3 months5. Who have undergone routine cardiac surgical care6. Where a decision to withdraw/withhold some critical care had been made7. Who are obviously brain dead

Investigators, research assistants and blood bank personnel will also exclude patients:8. When there are no red cells with a storage time of 7 days or less available in the blood bank that cannot be transported from the blood supplier9. Who require more than 1 unit of uncross-matched red cells10. With a known objection to blood transfusions11. With autologous blood donations12. Who pose difficulties in securing blood products (rare blood groups), and who are difficult to match